Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
|ClinicalTrials.gov Identifier: NCT01259557|
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : April 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Essential Blepharospasm||Drug: Botulinum Toxin Type A||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||August 2011|
U.S. FDA Resources
|Experimental: Botulinum toxin type A(Meditoxin®)||
Drug: Botulinum Toxin Type A
2 times, Intra-muscular injection, Maximum dosage total 60U
- the change rate of Jankovic Rating Scale score [ Time Frame: 4weeks ]To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).
- the change rate of Jankovic Rating Scale scale [ Time Frame: 0 week, 16weeks(or retreatment point) ]To evaluate the change of JRS(Jankovic Rating Scale) at retreatment point or 16 weeks post treatment based on Baseline(0 week).
- the change rate of Blepharospasm Disability Index [ Time Frame: 0week, 4weeks, 8weeks, 16weeks(or retreatment point) ]To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.
- Global assessment about the improvement [ Time Frame: 4weeks ]To evaluate the Global assessment about the improvement at 4weeks post treatment.
- the duration of efficacy [ Time Frame: retreatment point or 16 weeks ]To evaluate the duration of efficacy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259557
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|
|Seoul St.Mary Hospital|
|Seoul, Korea, Republic of, 137-040|
|Chung-Ang Univesity Yongsan Hospital|
|Seoul, Korea, Republic of, 140-883|
|Principal Investigator:||Jaechan Kim, M.D., Ph.D.||Chung-Ang university Yongsan Hospital|